Posted by Michael Wonder on 20 Feb 2021
Incyte announces acceptance and priority review of NDA for ruxolitinib cream for atopic dermatitis
19 February 2021 - Incyte today announced that the U.S. FDA has accepted for priority review the new drug application for ruxolitinib cream, a selective JAK1/JAK2 inhibitor designed for topical application, as a treatment for atopic dermatitis.
Incyte submitted a priority review voucher along with the NDA application for ruxolitinib cream. The use of the voucher shortens the review period by four months.
The Prescription Drug User Fee Act target action date is 21 June 2021.
